Senior Engineer I, Validation

BeOne Medicines Ltd

Base: $109,900.00 - $149,900.00 annually; bonus/eq...
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5 years biopharmaceutical validation experience
Cgmp regulatory compliance knowledge
Equipment qualification iq oq pq execution
** BeOne Medicines Ltd is seeking a Senior Engineer I in Validation to support its growing biopharmaceutical operations. The role involves managing validation activities, ensuring regulatory compliance, and leading projects while fostering a collaborative and innovative work culture. **

Job Summary

  • The role involves leading validation activities for equipment, processes, and products to ensure safety, quality, and regulatory compliance in a rapidly growing biotech environment.
  • Candidates will be responsible for developing and approving cGMP documents including Master Validation Plans, protocols, and reports while supporting internal and external audits.
  • The position offers competitive compensation with base salary ranging from $109,900 to $149,900 annually, along with equity awards and comprehensive benefits including medical and dental coverage.

Matching Summary

Match Score: 75

** BeOne Medicines Ltd is seeking a Senior Engineer I in Validation to support its growing biopharmaceutical operations. The role involves managing validation activities, ensuring regulatory compliance, and leading projects while fostering a collaborative and innovative work culture. **

Salary

Base: $109,900.00 - $149,900.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • 5 years biopharmaceutical validation experience
  • cGMP regulatory compliance knowledge
  • Equipment Qualification IQ OQ PQ execution
  • Process Validation PPQ and cleaning validation
  • Aseptic processing and sterile manufacturing
  • Risk assessment and deviation investigation

Nice-to-have

  • Computerized System Validation CSV expertise
  • Automation validation experience
  • SAP working knowledge
  • Strong leadership and communication skills
  • Proactive problem-solving attitude

Key Requirements

  • BS degree in engineering or related discipline
  • Minimum 5 years validation experience with Bachelor's degree
  • Experience in FDA-regulated biotechnology or pharmaceutical company
  • Scientific degree in pharmaceutical sciences, engineering, or chemistry preferred

Work Rights

Not specified

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